Regulatory Data Protection. To the extent required by law or permitted by law, each Party will use commercially reasonable efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Product that such Party intends to, or has begun to commercialize, and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "Orange Book" listings required under the Xxxxx-Xxxxxx Act and all so called "Patent Register" listings as required in Canada. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party holding the NDA for the applicable Product will retain final decision making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
Appears in 3 contracts
Samples: Research and Development Collaboration, Option and License Agreement (Anacor Pharmaceuticals Inc), Research and Development Collaboration, Option and License Agreement (Anacor Pharmaceuticals Inc), Research and Development Collaboration, Option and License Agreement (Anacor Pharmaceuticals Inc)
Regulatory Data Protection. To the extent required by law or permitted by law, each Party will use commercially reasonable efforts Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents Patent Rights for any Product that such Party intends to, or has begun to commercializeto, commercialize and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "“Orange Book" ” listings required under the Xxxxx-Xxxxxx Act and all so called "“Patent Register" ” listings as required in Canada. Prior to such listings, the Parties will meet to evaluate and identify all applicable PatentsPatent Rights. Notwithstanding the preceding sentence, the Party holding the NDA for the applicable Product will retain final decision decision-making authority as to the listing of all applicable Patents Patent Rights for such Product, regardless of which Party owns such PatentPatent Rights.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Prosensa Holding B.V.), Research and Development Collaboration and License Agreement (Prosensa Holding B.V.)
Regulatory Data Protection. To the extent required by law or permitted by law, each Party will use commercially reasonable efforts Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Product that such Party intends to, or has begun to commercializeto, commercialize and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "“Orange Book" ” listings required under the Xxxxx-Xxxxxx Act and all so called "“Patent Register" ” listings as required in Canada. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party holding the NDA for the applicable Product will retain final decision decision-making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Dynavax Technologies Corp), Research and Development Collaboration and License Agreement (Dynavax Technologies Corp)
Regulatory Data Protection. To the extent required by law or permitted by law, each Party will use commercially reasonable efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Product that such Party intends to, or has begun to commercialize, and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "“Orange Book" ” listings required under the Xxxxx-Xxxxxx Act and all so called "“Patent Register" ” listings as required in Canada. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party holding the NDA for the applicable Product will retain final decision making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
Appears in 1 contract
Samples: Research and Development Collaboration, Option and License Agreement (Anacor Pharmaceuticals Inc)
Regulatory Data Protection. 8.5.1 To the extent required by law or permitted by law, each Party will use commercially reasonable efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities regulatory authorities during the Termterm of this Agreement, all applicable Patents for any Product that such Party intends to, or has begun to commercialize, and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "“Orange Book" ” listings required under the Xxxxx-Xxxxxx Act and all so called "“Patent Register" ” listings as required in Canada. .
8.5.2 Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party holding the NDA responsible for marketing the applicable Product will retain final decision making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Pharmacopeia Drug Discovery Inc)
Regulatory Data Protection. To the extent required by law or permitted by law, each Party will use commercially reasonable efforts Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Termterm of this Agreement, all applicable Patents for any Product that such Party intends to, or has begun to commercialize, and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "“Orange Book" ” listings required under the Xxxxx-Xxxxxx Act and all so called "“Patent Register" ” listings as required in Canada. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party holding the NDA for the applicable Product will retain final decision making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
Appears in 1 contract
Samples: Commercial Research and License Agreement (Supergen Inc)